For the Consumer

Along with its needed effects, goserelin (the active ingredient contained in Zoladex 3-Month) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking goserelin:

Rare

Rare

Pain in the chest

pain in the groin or legs (especially in the calves of the legs)

Some side effects of goserelin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Some clinicians have used the addition of the oral progestational agent megestrol acetate to reduce the hot flashes. A dose of megestrol acetate 20 mg two times a day may be appropriate. Tumor flare may also occur in males if antiandrogens are not administered.[Ref]

Nervous system

Nervous system side effects including lethargy (M 8% to 26%), dizziness (F 6% and M 1% to 18%), paresthesia (M 12%), asthenia (F 11%), insomnia (F 5% to 11% and M 12%) and nervousness (F 3%) have been reported. Anxiety and urinary retention have been reported to occur in 1% to 5% of patients. Somnolence has also been reported. As a result of increased prostate tumor growth caused by initial testosterone level elevation, a case of spinal cord compression resulting in paraplegia has been reported.

Postmarketing nervous system side effects including convulsions have been reported.[Ref]

Gastrointestinal

Gastrointestinal side effects including constipation (M 12%), nausea (F 8% to 11% and M 5%), anorexia (M 5%), vomiting (F 4%) and increased appetite (2%) have been reported. Diarrhea and hematemesis have been reported to occur in 1% to 5% of patients. Ulcer, dyspepsia, dry mouth and flatulence have also been reported.[Ref]

Respiratory

Respiratory side effects including pharyngitis (F 5%) and voice alterations (F 3%) have been reported.[Ref]

Hypersensitivity

Hypersensitivity reactions, both at the injection site (F 6%) and to the whole body have been reported.[Ref]

Musculoskeletal

Musculoskeletal side effects including an average 4.3% decrease in vertebral trabecular bone mineral density (BMD) after six months of therapy (n=109 F patients), when compared to their pretreatment values. Myalgia (F 3%), leg cramps (F 3%) and hypertonia (F 1%) have been reported. Arthralgia and joint disorders have also been reported.[Ref]

Data suggest the decrease in BMD is partially reversible upon discontinuation of therapy.[Ref]

Metabolic

Metabolic side effects including gout, hyperglycemia, weight increase, and diabetes mellitus have been reported to occur in 1% to 5% of patients.[Ref]

Hematologic

Hematologic side effects including ecchymosis and sepsis have been reported to occur in 1% to 5% of patients.[Ref]

Ocular

Ocular side effects including amblyopia and dry eyes have been reported.[Ref]

Endocrine

Endocrine side effects including very rare cases of pituitary apoplexy have been reported. Reduction in glucose tolerance, manifesting as diabetes or loss of glycemic control in those with preexisting diabetes, has also been reported during treatment with GnRH agonists, including goserelin (the active ingredient contained in Zoladex 3-Month) [Ref]

Pituitary apoplexy is a clinical syndrome secondary to infarction of the pituitary gland. In a majority of the cases of pituitary apoplexy, a pituitary adenoma was diagnosed. Most of the pituitary apoplexy cases occurred within two weeks of the first dose, and some occurred within the first hour. In these cases, pituitary apoplexy has presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical attention has been required.[Ref]

Oncologic

Oncologic side effects including very rare cases of pituitary tumors have been reported.[Ref]